BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMELOCK REVERSED

    MDR report key: 9835539 · Received March 16, 2020

    Report

    Report Number
    3009532798-2020-00123
    Event Type
    Injury
    Date Received
    March 16, 2020
    Date of Event
    February 18, 2020
    Report Date
    March 16, 2020
    Manufacturer
    FX SOLUTIONS
    Product Code
    PHX
    PMA / PMN Number
    K162455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO A DISLOCATION OCCURRED (B)(6) 2020 APPROXIMATELY 14 MONTHS AFTER PRIMARY SURGERY ON (B)(6) 2018. 36/+6 HUMERAL CUP WAS REMOVED AND REPLACED BY 36/+9 HUMERAL CUP AND +9 HUMERAL SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297377 HUMELOCK REVERSED REVERSED SHOULDER PROTHESIS PHX FX SOLUTIONS L2793

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R